Solid Tumor, Adult Clinical Trial
Official title:
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX35 (Recombinant Humanized Anti-EGFR and Anti-4-1BB Bispecific Antibody Injection) in Combination With HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors
This is a phase I clinical study designed to evaluate the safety, tolerability, PK characteristics, and preliminary efficacy of HLX35 in combination with HLX10 in patients with advanced or metastatic solid tumors.
For HLX35, 5 dose levels are set, starting at 0.1 mg/kg, q2w, followed by gradually escalating doses of 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg; for HLX10, a fixed dose of 200 mg is set, q2w, without dose escalation. The "3 + 3" design is used for dose escalation in this study. ;
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